Health

FDA Holds Meeting on New Female Condom

By Molly M. Ginty

WeNews correspondent

Thursday, December 11, 2008

On Dec. 11, an FDA committee will vote on a pre-market approval application for a cheaper version of the female condom, first introduced 14 years ago. The product is hailed as an important tool in preventing AIDS, but is poorly promoted.

(WOMENSENEWS)--It's squeaky, squishy, baggy and bunchy. And it could help save women's lives.

That's the word on a new female condom that a Food and Drug Administration committee may recommend for market approval today.

Like the other version of the female condom--the "FC" approved by the FDA in 1994--the second-generation "FC2" is made by the Chicago-based Female Health Company. Just as effective as its predecessor at preventing unwanted pregnancy, HIV and other sexually transmitted infections, the new version is made of nitrile, a cheaper material than the older version's polyurethane, and is 30 percent less expensive.

Cost estimates range from $1.40 to $2.10 for consumers and about half that for health care organizations that distribute it. The new condom has won support from women's advocates for its reduced price and because women can insert it without a sexual partner's help.

"Our interest in seeing a second-generation female condom comes from the changing face of the AIDS epidemic," says Kirsten Moore, president of the Washington-based Reproductive Health Technologies Project. "With the growing number of women becoming infected with HIV, we clearly need more and better female-controlled prevention options."

The women's health organizations scheduled to speak before the FDA's Obstetrics and Gynecology Devices Advisory Committee today include representatives of the Atlanta-based SisterLove; the Washington-based National Women's Health Network; and the Washington-based National Research Center for Women and Families. They will convene in Gaithersburg, Md., near the FDA's headquarters in Rockville, Md.

Eighty-seven U.S. advocacy groups and 50 international groups are submitting a petition in favor of FC2. Other health authorities, such as the New York-based Guttmacher Institute, are submitting separate letters of support.

Health advocates say that if the government moves quickly in recommending FC2 approval, the new condom could be on U.S. pharmacy shelves--and in the hands of aid organizations that distribute it worldwide--some time in 2009.

Strong Research Backing

The old-style FC female condom is available in the United States and 108 other countries. It is 95 percent effective at preventing pregnancy if used correctly and 80 percent effective if not used correctly every time, reports the Washington-based Planned Parenthood Federation of America. It reduces the risk of sexually transmitted infection by 97 percent, studies from the United States and Thailand show.

Research from Japan, Great Britain and Madagascar indicates the newer version has the same efficacy rates. Except for the different material, FC2 is otherwise indistinguishable from FC. It has the same baggy, six-and-a-half-inch cylindrical shape; a tube with flexible rings at both ends, with one end open and the other end closed.

Both versions are safe for people who have allergies to the latex found in male condoms. Both can be used for anal as well as vaginal sex, and both stay in place whether or not a male partner has a full erection.

"I find it empowering to be able to take charge and put on the female condom myself," says Linda Arnade, a health worker in Chicago who has used FC for three years. "I like being able to put it in several hours before sex, and the fact that the material feels stronger than latex. I once had a male condom break, but that's never happened to me with the female condom."

Alongside these advantages come some drawbacks.

"The female condom's biggest problem is likely its cost," says Amy Allina, program director of the National Women's Health Network. "The high price makes it difficult for consumers and aid organizations to afford consistent supplies." Female condoms are roughly seven times more expensive than male condoms.

There's also the problem of customer complaints.

"Some women report that the female condom squeaks," says Serra Sippel, executive director of the Washington-based Center for Health and Gender Equity. "But more lubrication can help with that problem, and the newer version is supposed to be less noisy."

"My partner and I got a female condom more than a year ago," says Leslie Booker, a youth advocate in New York City. "We're curious about using it, but every few months, we take it out and stare at it just don't know where to begin because it's so baggy, bulky and unwieldy."

To use the female condom correctly and prevent slippage, women must follow the device's diagramed instructions, learning how to pinch the condom's inner ring, slip that ring inside the vagina and fit around the cervix, all while fitting the outer ring snugly around the labia.

A Growing Need

Health advocates say the female condom would likely win more converts if there was a concerted effort to educate women about how it works. Manufacturer studies show 50 to 70 percent of users find the device acceptable once they have experience using it.

Due to a lack of investment, education efforts have so far fallen flat.

"We're a small manufacturing company, and we just haven't had the resources to mount massive marketing campaigns," says Jack Weissman, a vice president at the Female Health Company of Chicago, the sole maker and supplier of the FC and FC2.

Women's advocates say a combination of high costs, limited availability, insufficient political will and a lack of social acceptability pose problems in promoting the product. That's especially true in AIDS-ravaged regions such as Africa, where 75 percent of HIV-positive women live and where female condoms may be needed most.

"Nongovernmental organizations in Africa have clients who want female condoms, but they don't have enough of them to hand out," says Anna Forbes, deputy director of the Washington-based Global Campaign for Microbicides. "One health worker in Rwanda told me she mentions the female condom as part of her HIV-prevention workshop, but has never actually seen one herself. Female condoms are in fact so rare that they represent just 0.2 percent of the world's total condom supply."

As they make their case to the FDA committee today, health advocates plan to stress the needs of at-risk women who receive female condoms through national and international health programs, which distribute more than 90 percent of the 35 million female condoms manufactured each year.

More than 15.5 million women worldwide are HIV-positive, and women comprise half of all HIV cases, reports the Geneva-based World Health Organization. More than 280,000 U.S. women have HIV, and its incidence among them has quadrupled in the past two decades, reports the Atlanta-based Centers for Disease Control and Prevention.

"Because FC2 has been approved by the World Health Organization, it is already being purchased and used by international aid organizations that don't rely on FDA approval," says Sippel. "But health organizations here must wait for FDA approval, which could greatly help them in their efforts to save more women's lives."